Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial — PEPP - RCT  

Depression Clinical Trial

Official title: Program for Emotional and Physical Pain - Pilot Randomized Clinical Trial

Status Completed

Clinical Trial Summary

The overall aim of this program of research is to develop a collaborative psychotherapy for major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid chronic low back pain (CLBP).

The purpose of the proposed project is to establish the feasibility and acceptability of a research design for an eventual large-scale randomized clinical trial which would test the efficacy of PEPP in comparison to a control condition (depression care management).

To achieve the investigators specific aims, the investigators will conduct a pilot randomized clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in care management) or care management.

Clinical Trial Description

The overall aim of this program of research is to develop a collaborative psychotherapy for major depressive disorder (MDD) specifically for primary care patients with MDD and comorbid chronic low back pain (CLBP). The newly developed intervention will integrate and build on behavior therapy for MDD and behavior therapy for chronic pain towards a key target of reducing behavioral avoidance. This 4-month collaborative psychotherapy, entitled Program for Emotional and Physical Pain (PEPP), will include 1 joint meeting with the behavioral health specialist (BHS), primary care provider (PCP), and patient, 10 psychotherapy sessions, and continued collaboration between the BHS and the PCP to assure a shared treatment plan.

The purpose of the proposed project is to establish the feasibility and acceptability of a research design for an eventual large-scale randomized clinical trial which would test the efficacy of PEPP in comparison to a control condition (depression care management)..

To achieve the investigators specific aims, the investigators will conduct a pilot randomized clinical trial (n = 30), with two treatment arms; PEPP (which includes procedures used in care management) or care management. The specific aims are:

1. To develop and refine PEPP so that it meets standards of feasibility and acceptability for primary care physicians (PCPs), behavioral health specialists (BHSs), and participants;

1. To develop, field-test, and finalize a PEPP manual;

2. To develop a reliable measure of BHS adherence to the manual;

3. To develop, field-test, and finalize BHS training and supervision procedures;

2. To field-test and finalize procedures for depression care management;

3. To establish that the investigators can adequately provide depression care management and that it is acceptable in this population;

4. To develop and refine recruitment methods for an RCT and document an adequate rate of recruitment;

5. To refine research procedures, e.g., consent process, randomization process, and assessment procedures, and establish their feasibility and acceptability to participants.

Ultimately, the investigators expect that this treatment development work will prepare us to apply for an R01 to conduct a large-scale, adequately powered RCT with the same research design as the pilot RCT proposed in this application. Depression will be the primary outcome variable assessed in the large-scale RCT; pain will be a secondary outcome variable. In the end, the investigators believe this line of work will lead to the incorporation into primary care of theoretically-driven and effective mental health treatment for patients with MDD and comorbid CLBP. To the best of the investigators knowledge, this would be the first empirically-tested psychotherapy protocol that specifically integrates treatment of major depression with CLBP. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Low Back Pain
• Depression
• Low Back Pain

• NCT number: NCT01769729
• Study type: Interventional
• Source: Butler Hospital
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Completion date: February 2014